China’s growing role in clinical development is one of the biggest talking points of the past few years at pharma events over the past couple of years. Tales of speedy development, top class clinical talent and enviable trial recruitment rates mean that China can’t be ignored as a potential clinical development option.
To get under the skin of this topic, we decided to dig around in Citeline’s proprietary clinical trial data to see what the China advantage really looks like. Norstella’s Daniel Chancellor was joined by Citeline’s Kirsty Lyne and Hsingmei Wu as they walked through the data to reach some fascinating conclusions.
There was a lot to cover in the session and I recommend catching the full webinar on demand, but in the meantime here are three things I learned.
- China now runs more than half of all Phase I oncology trials globally. That figure,7% of single-country, industry-sponsored Phase I oncology trials between 2016 and 2025, sets the context for everything else. The US accounts for 28.2%, the rest of the world shares the remainder. Interestingly, China is achieving that volume through 882 participating sites, while the US runs roughly half that trial count across nearly twice the number of sites. That’s about three trials per site in China against fewer than one in the US.
- China enrolls faster. Chinese Phase I oncology sites are running at 1.6 times the pace of US counterparts, with a median enrollment duration of 15 months against 19.6 in the US, a 4.6-month difference on trials targeting a near-identical number of patients. The team also checked healthy volunteer and rare disease trials and found the same pattern.
- Western sponsors are barely present in Phase I China. Around 85% of Phase I activity in China is driven by Chinese-headquartered companies while Western pharma accounts for roughly 10%. At later phases, Western sponsors are already including Chinese sites as standard. The hesitation is concentrated at Phase I, but the data offers a reason to revisit it: China has around 4.5 investigators per site against two in the US, which suggests available capacity even within a smaller site footprint.
The on-demand recording covers lots more ground, including questions on IP considerations and the regulatory acceptability of China-generated data for Western submissions. Grab a snack and watch it here.
